Biogenex Laboratories, Inc.: Medical Device Recall in 2014 - (Recall #: Z-2113-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

InSite HER-2 Detection Kit, an immunohistochemistry assay for in vitro diagnostic use.

Product Classification:

Class II

Date Initiated: July 1, 2014

Date Posted: July 30, 2014

Recall Number: Z-2113-2014

Event ID: 68709

Reason for Recall:

Product was distributed without 510(k) approval.

Status: Terminated

Product Quantity: 4 kits

Code Information:

Catalog number RD471-60K: Lot numbers: RD4710111, Exp Jan 2012; RD4710411, Exp. Apr 2012; RD4711013, Exp Oct 2014.

Distribution Pattern:

Brazil and Ecuador. No US distribution

Voluntary or Mandated:

Voluntary: Firm initiated